What Is a Drug Safety Communication from the FDA?

A drug safety communication from the FDA is not a warning you ignore. It’s not a press release you skim and forget. It’s a direct message from the U.S. Food and Drug Administration telling doctors, pharmacists, and patients: something about this medicine has changed, and you need to know why.

These aren’t just routine updates. They’re triggered when new evidence shows a drug might be riskier than originally thought - or when a known risk turns out to be more common, more severe, or affects new groups of people. The FDA doesn’t issue these lightly. Each one means a safety signal has been detected through real-world data: adverse event reports, hospital records, long-term studies, or even patient surveys. And when that signal passes a certain threshold, the FDA acts - fast.

How Do These Communications Actually Work?

Every drug safety communication follows the same clear structure. It starts with: What safety concern is the FDA announcing? Then it breaks down what the problem is, who it affects, and what you should do about it.

For example, in July 2025, the FDA issued a communication about extended-release opioid pain medications. The issue? Long-term use was linked to higher rates of addiction, misuse, and fatal overdose - even in patients taking them exactly as prescribed. The communication didn’t just say, “Be careful.” It told doctors: Re-evaluate whether these drugs are still appropriate for chronic pain. Consider alternatives. Reduce doses in older adults. And it told patients: If you’ve been on this medication for years, talk to your doctor before making any changes.

These aren’t vague suggestions. They’re specific, actionable steps backed by data. The FDA uses reports from its MedWatch system, which collects over 1 million adverse event reports annually. It also taps into the Sentinel Initiative - a network that monitors health records from 300 million Americans. When patterns emerge - like a spike in liver damage tied to a specific antibiotic - the FDA investigates. If the risk is real and significant, they issue a communication.

Why Do They Take So Long to Come Out?

It’s a common complaint: “Why did it take them two years to tell us about this?”

From 2010 to 2020, the average time between spotting a safety signal and issuing a public communication was 2.6 years. That delay meant some patients were exposed to unnecessary risks. But things are changing.

In 2025, thanks to new AI tools that scan millions of health records in real time, the median time dropped to 1.8 years. The FDA now shares preliminary findings earlier - even while they’re still analyzing the data. You might see a communication that says: “We’re seeing a possible link between this drug and kidney injury. We’re still investigating, but if you’re at risk, talk to your doctor.”

This shift matters. It means you’re not waiting for a final verdict. You’re getting early warnings so you can make smarter choices while the science catches up.

Who Gets These Messages - And Do They Actually Change Behavior?

These communications go out to 147,832 healthcare professionals who’ve signed up for FDA email alerts. Hospitals like Mayo Clinic and Kaiser Permanente integrate them directly into their electronic health record systems. But here’s the problem: not everyone sees them.

A 2024 survey found that 68% of hospital pharmacists check the FDA’s Drug Safety page weekly. Only 42% of community pharmacists do. In rural clinics, where staff are stretched thin, these alerts often get buried under paperwork.

And what about patients? When the FDA warned about proton pump inhibitors (PPIs) and the risk of C. difficile infection in 2022, 73% of patients told their doctors. But only 38% actually stopped or switched medications. Why? Because changing a long-term prescription isn’t simple. Patients fear side effects from new drugs. They don’t understand the risk. Or their doctor didn’t push the issue.

That’s why the FDA now includes plain-language patient sections in 47% of recent communications - up from just 28% in 2018. These aren’t just summaries. They’re written in clear, everyday language: “This medicine may increase your chance of getting a serious stomach infection. If you have diarrhea that doesn’t go away, call your doctor.”

What Happens After the Communication?

A drug safety communication isn’t the end - it’s the beginning of possible regulatory action.

If the risk is serious enough, the FDA may:

• Require the manufacturer to update the drug’s label with new warnings
• Implement or strengthen a Risk Evaluation and Mitigation Strategy (REMS) - which could mean restricted distribution, mandatory training for prescribers, or patient registries
• Order new post-market studies to gather more data
• In rare cases, pull the drug from the market

For example, after a 2017 communication about the risk of severe skin reactions with carbamazepine, the FDA required genetic testing before prescribing it to patients of Asian descent. That single change saved lives.

On the other side of the coin, some communications lead to no action at all. Sometimes, the risk is real - but too rare to justify changing how the drug is used. Other times, the benefit still outweighs the risk. The FDA doesn’t scare people for no reason. It weighs the harm against the help.

How Do You Keep Up With Them?

If you’re a patient, you don’t need to track every single one. But if you take multiple medications - especially long-term - you should know how to find them.

The FDA’s Drug Safety Communications page lets you filter by drug name, date, or condition (like heart disease, diabetes, or mental health). You can sign up for email alerts or subscribe to their RSS feed. If you’re a caregiver for an elderly parent or someone with chronic illness, set a reminder to check the page every few weeks.

For healthcare providers, the American College of Physicians recommends spending 15 to 20 minutes a week reviewing new communications. Many hospitals now have pharmacists dedicated to monitoring these alerts. But if you’re in a small practice, you’re on your own. Bookmark the page. Turn on notifications. Don’t assume your pharmacy or EHR system will catch everything - because many don’t.

What’s Next for Drug Safety?

The FDA isn’t slowing down. By 2027, they expect to issue over 200 safety communications a year - up from 187 in 2024. Why? Because the drugs are getting more complex. Gene therapies. AI-powered diagnostic tools. Customized cancer treatments. These aren’t pills you swallow. They’re living, evolving treatments with unknown long-term effects.

The FDA is also testing new ways to deliver alerts. In 2026, they plan to launch a system that uses AI to analyze electronic health records in real time - flagging potential dangers before they become widespread. Imagine your doctor getting an alert the moment a patient starts a new drug that’s known to interact dangerously with another medication they’re already taking.

But technology alone won’t fix the problem. The biggest challenge remains: getting people to act. A 2025 Johns Hopkins study found that only 61% of critical safety recommendations led to real changes in prescribing within six months. That means nearly four in ten patients are still being exposed to known risks.

So what can you do? Stay informed. Ask questions. If your doctor prescribes a new drug, ask: “Has there been any recent safety information about this?” If you’ve been on a medication for years, ask: “Has anything changed about its risks?”

Drug safety communications aren’t meant to scare you. They’re meant to empower you. They’re the FDA’s way of saying: we’re watching. And now, so are you.